This study was designed to compare the efficacy and safety of Becotatug Vedotin (MRG003) combined with Pucotenlimab as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.
Aged 18 to 75 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy ≥ 3 months.
Histologically or cytologically confirmed nasopharyngeal carcinoma (NPC).
Peripheral neuropathy of Grade 2 or higher.
Anticipated need for any other local or systemic anti-tumor therapy during the study period.
Diagnosed and/or treated additional malignancy within 5 years of enrollment, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical and/or breast carcinoma.
Active central nervous system (CNS) metastases or carcinomatous meningitis.
Single group
Becotatug Vedotin and Pucotenlimab
DrugBecotatug Vedotin (2.0mg/kg, ivgtt, every 3 weeks, D1) combined with Pucotenlimab (200mg, ivgtt, every 3 weeks, D1) is administered until disease progression (PD), unacceptable toxicity, or death.
Progression Free Survival (PFS)
Defined as the period from treatment initiation until disease progression or death from any cause, whichever occurs first.
Objective Response Rate (ORR)
Defined as the proportion of patients whose tumors shrink to complete response (CR) or partial response (PR) and remain for a certain period of time according to RECIST 1.1.
The proportion of patients who achieved disease control
Defined as the proportion of subjects who achieve CR+PR+stable disease (SD) for a certain period of time according to RECIST 1.1.
Duration of Response (DoR)
Defined as the time from the first assessment of CR and PR to the first assessment of PD or death caused by any cause according to RECIST 1.1.
Overall Survival (OS)
Defined as the period from treatment initiation until death from any cause.
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